AVEO initiates enrollment in tivozanib and mFOLFOX6 Phase 2 combination trial for CRC

AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO) today announced the initiation of patient enrollment in an open-label, multicenter, randomized Phase 2 clinical trial, called BATON-CRC, evaluating tivozanib in combination with modified FOLFOX6 (mFOLFOX6) compared to bevacizumab in combination with mFOLFOX6 as first-line therapy in patients with advanced metastatic colorectal cancer (CRC). BATON-CRC is the second trial to be initiated as part of the BATON (Biomarker Assessment of Tivozanib in ONcology) program, a series of clinical trials planned to assess tivozanib biomarkers in solid tumors. BATON-RCC, a Phase 2 exploratory biomarker study in patients with advanced renal cell carcinoma, was initiated by AVEO in early 2011.

"There have been a number of advances in the treatment of metastatic colorectal cancer, particularly over the past decade, which have extended patients' survival; however, there remains an urgent need for new agents to further improve outcomes for patients," said Al Benson, M.D., F.A.C.P., professor of medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine, and BATON-CRC primary investigator. "It is critical that we develop strategies that will enhance our understanding of patient populations that will best respond to specific therapeutic regimens, and I believe that BATON-CRC is a step forward on this front. I am excited to be involved in this trial and to learn more about how this treatment regimen with tivozanib may benefit patients living with colorectal cancer."

BATON-CRC, which is being led by AVEO's collaborator Astellas Pharma Inc. (Tokyo:4503, "Astellas"), will enroll approximately 252 patients with no prior VEGF-targeted therapy at approximately 80 centers in the U.S., Canada, Australia and Europe. Patients will be randomized to one of the two treatments arms in a 2:1 ratio (168 patients in the tivozanib arm and 84 patients in the bevacizumab arm). One component of BATON-CRC is the assessment of biomarker relationships that may be predictive of response, including lactate dehydrogenase (LDH). LDH is a protein that normally appears throughout the body in small amounts and can be elevated in patients with certain cancers, including colorectal cancer. Measuring LDH levels can be helpful in monitoring cancer treatment and determining patients' response to therapy. For additional information, please visit clinicaltrials.gov.

"BATON-CRC is further example of AVEO's commitment to patient care and advancing the science behind biomarkers," said William Slichenmyer, M.D., Sc.M., chief medical officer at AVEO. "The identification and development of relevant biomarkers through our Human Response Platform is a core component of our oncology drug development efforts. We plan to use biomarker data from BATON-CRC and BATON-RCC to inform our clinical development strategy in an effort to bring tivozanib to the patients who will benefit most."

A Phase 1b clinical trial evaluating tivozanib in combination with mFOLFOX6 in patients with advanced gastrointestinal (GI) cancers, including colorectal cancer, was completed by AVEO last year. Results showed partial responses in more than a third (35 percent) of patients evaluated.